The Canadian Follow-up Program for the ATTRACT Study (P04868)(TERMINATED)

This study has been terminated.
(Challenging data collection)
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00748930
First received: September 5, 2008
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

This is a Phase 4, retrospective chart review of subjects that participated in the ATTRACT study. Site investigators will conduct a chart review and complete a data collection form. The purpose of this study is to describe the treatment used and clinical outcomes of these subjects following completion of the ATTRACT trial up until their most recent assessment by the treating physicians.


Condition Intervention
Arthritis, Rheumatoid
Other: Retrospective Chart Review and Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Canadian ATTRACT Follow-up Program

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • To describe the treatment used after completion of the ATTRACT trial in patients enrolled as subjects in the ATTRACT trial from Canadian sites. [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • To describe the long-term therapeutic response as measured by the ACR status in patients enrolled as subjects in the ATTRACT trial from Canadian sites. [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To describe the long term safety of infliximab in patients enrolled as subjects in the ATTRACT trial from Canadian sites. [ Time Frame: Adverse events will be recorded only for the period after completion of the ATTRACT follow-up. ] [ Designated as safety issue: Yes ]
  • Disease Activity Score (DAS) [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Morning stiffness [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Swollen joint count [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Tender joint count [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Rheumatoid factor (RF) presence [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • C-reactive Protein (CRP) values [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Erythrocyte Sedimentation Rate (ESR) values [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Annualized X-ray Progression before and after infliximab [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Pain Score [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Patient Global Assessment of Disease Status [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Physician Global Assessment of Disease Status [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]
  • Healthcare Utilization [ Time Frame: There are no study specific visits, or patient assessments. Measurements to be recorded for the following time points: Prior to enrollment in ATTRACT, at completion of ATTRACT and for a minimum of three time points after completion of ATTRACT follow-up. ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: September 2006
Study Completion Date: October 2007
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cohort 1
Subjects previously enrolled in the ATTRACT trial from three Canadian sites.
Other: Retrospective Chart Review and Data collection
Retrospective Chart Review and Data collection

Detailed Description:

Subjects were selected for this study using a non-probability sampling method.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects previously enrolled in the ATTRACT trial from three Canadian sites.

Criteria

Inclusion Criteria:

  • Patients must have been enrolled in the two year follow-up phase of ATTRACT and have continued treatment with the site investigator
  • Signature of informed consent.

Exclusion Criteria:

  • Not specified in the protocol.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier: NCT00748930     History of Changes
Other Study ID Numbers: P04868
Study First Received: September 5, 2008
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 21, 2014